Modular external infusion device

ABSTRACT

A modular external infusion device that controls the rate a fluid is infused into an individual&#39;s body, which includes a first module and a second module. More particularly, the first module may be a pumping module that delivers a fluid, such as a medication, to a patient while the second module may be a programming module that allows a user to select pump flow commands. The second module is removably attachable to the first module.

RELATED APPLICATION DATA

This is a continuation of U.S. patent application Ser. No. 13/948,542,filed Jul. 23, 2013, now U.S. Pat. No. ______, which is a continuationof U.S. patent application Ser. No. 13/397,991, filed Feb. 16, 2012, nowU.S. Pat. No. 8,517,987, which is a continuation of U.S. patentapplication Ser. No. 12/727,170, filed Mar. 18, 2010, now U.S. Pat. No.8,152,764, which is a continuation of U.S. patent application Ser. No.11/225,359, filed Sep. 13, 2005, now U.S. Pat. No. 7,713,240, all ofwhich are incorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

Embodiments of this invention are related generally to an externalinfusion device, and more particularly, to a modular external infusiondevice that controls the rate a fluid is infused into an individual'sbody.

2. Description of Related Art

Infusion devices and systems are relatively well known in the medicalarts, for use in delivering or dispensing a prescribed medication suchas insulin to a patient. In one form, such devices comprise a relativelycompact pump housing adapted to receive a syringe or reservoir carryinga prescribed medication for administration to the patient throughinfusion tubing and an associated catheter or infusion set.

Infusion devices and systems generally include a display and an inputdevice. In infusion devices known in the art, the display and inputdevice are part of the pump housing. Thus, the entire infusion device,including any input and output devices, is composed in a unitaryhousing. A drawback to these infusion devices is that they may be toobulky and/or heavy to conveniently wear.

There are a number of infusion devices developed to alleviate theproblems associated with weight and bulkiness. Such infusion devices mayinclude a small drive motor connected via a lead screw assembly formotor driven advancement of a reservoir piston to administer themedication to the user. Programmable controls can operate the drivemotor continuously or at periodic intervals to obtain a closelycontrolled and accurate delivery of the medication over an extendedperiod of time. These infusion devices are used to administer insulinand other medications, with exemplary pump constructions being shown anddescribed in U.S. Pat. Nos. 4,562,751; 4,678,408; 4,685,903; 5,080,653;5,097,122, and 6,551,276, which are incorporated by reference herein.

Infusion devices of the general type described above have providedsignificant advantages and benefits with respect to accurate delivery ofmedication or other fluids over an extended period of time. The infusiondevice can be designed to be extremely compact as well as waterresistant, and may thus be adapted to be carried by the user, forexample, by means of a belt, clip, or the like. As a result, importantmedication can be delivered to the user with precision and in anautomated manner, without significant restriction on the user's mobilityor life style, including in some cases, the ability to participate inwater sports. However, there remains a need in the art for an infusiondevice, with the capabilities of the above-described infusion devicesbut, that is also capable of being even more compact.

BRIEF SUMMARY OF THE INVENTION

In accordance with embodiments of the invention, a modular externalinfusion device is provided that controls the rate a fluid is infusedinto an individual's body. An embodiment of the present inventionincludes a first module and a second module. The first module may be apumping module that delivers a fluid, such as a medication, to apatient.

The second module is removably attachable to the first module. In oneembodiment, the second module may be attached by sliding onto the firstmodule. Alternatively, the second module may be attached to the firstmodule by parts, such as sliding parts that mate. In another embodiment,the second module may be attached to the first module by snapping partsthat mate. Other alternatives, such as screwing components, hook andloop fasteners (e.g., Velcro™), adhesives, and the like, may also beused.

In further embodiments, the second module is a programming module thatallows a user to select pump flow commands. In these embodiments, thesecond module contains a user interface and controls the first module.Where the first module is a pumping module, the second module preferablycontrols the pumping of the first module. The control by the secondmodule of the first module does not necessarily need to be constant orcontinuous. For example, in a preferred embodiment, the second moduleinputs a pumping schedule to the first module. The first module willthen pump based on the inputted schedule without any further inputs fromthe second module. In this way, the first module may continue itspumping schedule even when disconnected from the second module.

The pumping of the first module may be driven by any desired drivemechanism. Example drive mechanisms include, but are not limited to,gas, drive syringe, and electrolytic.

In particular embodiments, the second module has a display with one ormore input devices, such as for example, buttons or keys. The displaymay be a touch screen display that can be used in conjunction with theinput devices. The touch screen may be used in conjunction with, or asan alternative to, the buttons or keys. The display may be adapted todisplay various icons on the touch screen display, includingmulti-national icons that can be interpreted by users regardless oflanguage. Display settings may be customizable, including, but notlimited to, the background, sounds, fonts, and wallpaper. Differentdisplay features may be provided by the module and/or may be downloadedfrom a computer.

The second module may communicate with the first module by any suitablemethod. For example, the communication may be a direct connection, as byelectrical contacts or wire. Alternatively, it may be a wireless method,such as radio frequency (RF) or magnetic induction.

In a preferred embodiment where the second module controls the pumpingof the first module, the first module contains a pumping mechanism. Thepumping mechanism can be any mechanism known in the art and suitable forpumping fluid. The first module can be used with or without the secondmodule. It preferably can operate semi-independently from the secondmodule while keeping in contact with it. It is preferably compact sothat it can be worn under clothing if desired.

The second module may be used in conjunction with the first module, forexample, to control the pumping features. It may also be used forstand-alone applications, such as sensing an analyte level of thepatient. The second module may have a sensor interface, an analytemeter, or both. The analyte may be, for example, blood glucose. Thesensor may be, for example, a glucose sensor. The blood glucose metermay be housed in the second module. The second module may have areceiver, in addition to or instead of the blood glucose meter, toreceive information transmitted from a separate blood glucose meter. Thesecond module may be configured to communicate with a blood glucosemeter and/or a glucose sensor. The communication between the secondmodule and the blood glucose meter and/or glucose sensor may be wirelessor wired.

In particular embodiments of the invention, the first module and/or thesecond module may have one or more alarms. Alarms may be audible,tactile, and/or visual. Alarms may indicate low or high blood glucoselevels or infusion device problems, such as for example, blockages oroverdelivery of fluids in the pump. In certain embodiments, the alarmmay sound whenever blood glucose levels go beyond a programmed orallowed range. The second module may also include alarm(s) where thefirst module does not include any. The second module and/or the firstmodule may include a speaker, which may be configured to output alarmsand other sounds. The sounds may sound like a buzzer or another noise.The sounds may be words. For example, if the user's blood glucose ishigh, an alarm may be a sound that states, “Your blood glucose is high.”

One or both of the second module and the first module may communicate toa personal commuter. The communication may be wired or wireless. Forexample, the modules may communicate with the computer when insertedinto a docking station or when connected by a wire to the computer. Thecommunication may be wireless, such as RF, Bluetooth, or any otherwireless method.

In further embodiments, a computer software program may be used that isessentially a virtual second module. The same commands and controls thatexist in the second module may exist in the computer program. The secondmodule may be synched with the computer program on the computer, so thatchanges made on the computer are indicated in the second module, andvice versa.

The first module may have a button or switch or other input device tostop the pump in an emergency. To avoid accidental activation of theemergency stop, there may be a safety feature implemented. For example,if the emergency stop is a button, the stop might not be activated untilthe button is pressed for a continuous period of time, for example twoseconds. In an alternative, there may be two buttons that both need tobe pressed at the same time.

Other features and advantages of the invention will become apparent fromthe following detailed description, taken in conjunction with theaccompanying drawings, which illustrate, by way of example, variousfeatures of embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

A detailed description of embodiments of the invention will be made withreference to the accompanying drawings, wherein like numerals designatecorresponding parts in the several figures.

FIG. 1 is a perspective view of a modular external infusion device inaccordance with an embodiment of the present invention.

FIG. 2 is a perspective view of a modular external infusion device witharrows indicating the manner in which a first module and a second modulefit together in accordance with an embodiment of the present invention.

FIG. 3 is a top view of a second module displaying a Notes Menu inaccordance with an embodiment of the present invention.

FIG. 4 is a top view of a second module displaying a Screen Menu inaccordance with an embodiment of the present invention.

FIG. 5 is a top view of a second module displaying a View Menu as a rootmenu for three submenus in accordance with an embodiment of the presentinvention.

FIG. 6 is a simplified block diagram of a first module in accordancewith an embodiment of the present invention.

FIG. 7 is a simplified block diagram of a second module in accordancewith an embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

In the following description, reference is made to the accompanyingdrawings which form a part hereof and which illustrate severalembodiments of the present inventions. It is understood that otherembodiments may be utilized and structural and operational changes maybe made without departing from the scope of the present inventions.

As shown in the drawings for the purposes of illustration, the inventionis embodied in a modular external infusion device. In preferredembodiments, the modular external infusion device includes a firstmodule and a second module. In further preferred embodiments, the firstmodule is a pumping module, which is adapted to deliver a fluid to apatient. The fluid may be a medication, such as insulin.

In preferred embodiments, the second module contains a user interfaceand controls the first module. Where the first module is a pumpingmodule, the second module may be a programming module and preferablycontrols the pumping of the first module. The control by the secondmodule of the first module is not necessarily a continuous control. Forexample, in a preferred embodiment, the second module communicates apumping schedule to a first module. The first module will then pumpbased on the inputted schedule without any further communicates from thesecond module. The inputted schedule may be stored in a memory, such asa flash memory. In this way, the first module may continue its pumpingschedule even when disconnected from the second module.

The pumping of the first module may be driven by any desired drivemechanism. Example drive mechanisms include, but are not limited to,gas, drive syringe, and electrolytic.

As shown in FIG. 1, the modular external infusion device according toembodiments of the invention includes a second module 100 and a firstmodule 200. Although the second module 100 is shown as resting on top ofthe first module 200, the second module 100 could be on the bottom, thetwo modules could rest side-to-side, or they could be configured in anyother way that allows the two modules to be placed together. The firstmodule 200 contains the pumping mechanism. The pumping mechanism can beany one of the suitable pumping mechanisms in the art. For example, thepumping mechanism may include a piston-type drive system as described inU.S. Pat. No. 6,248,093, which is herein incorporated by reference.Further exemplary infusion device constructions are shown and describedin U.S. Pat. Nos. 4,562,751; 4,678,408; 4,685,903; 5,080,653; and5,097,122. In certain embodiments, the second module controls thepumping of the first module. The second module may also include a bloodglucose meter and/or could interface with any desired, available bloodglucose meter. It may also be configured to mate with or slide over ablood glucose meter.

As shown in FIG. 2, in certain embodiments, the second module 100 isremovably attachable to the first module 200. For example, the secondmodule 100 may be attached to the first module 200 by sliding parts 102,202 that mate. In another embodiment, the second module may be attachedto the first module by snapping parts that mate. Other alternatives,such as screwing components, hook and loop fasteners (Velcro™),adhesives, and the like, may also be used. In this manner, the secondmodule may be easily removed and attached from the first module withoutinterrupting or discontinuing the pumping schedules. Consequently, theuser is given an option to wear the first module without the secondmodule, making the infusion device even lighter and less bulky.

Although the second module and the first module are shown as beingblock-shaped, they could be shaped in a number of different ways. Forexample, the second module could be shaped in any way that is suitableto interface with the first module and to allow the user to view thedisplay and input commands. The first module could be shaped in a waythat is able to hold a desired amount of medication. Example shapesinclude, but are not limited to, a pen shape, a flat shape, and a roundshape. A hospital pump may also be used as the first module.

As shown in FIGS. 1 and 2, the second module 100 has a display 101. Thedisplay acts as part of a user interface. The display may be, forexample, an organic light emitting diode (OLED) display, a lightemitting diode (LED) display, and a liquid crystal display (LCD). In anembodiment with the OLED display, the display is self luminous andconsequently does not require an additional backlight to illuminate thedisplay. The display may be a touch screen display that allows the userto touch the screen to input data and/or commands into the secondmodule.

In addition to, or instead of (in the case of a touch screen display)the display, the second module may have one or more input devices, suchas buttons or keys for example. In further embodiments, alternativeinput devices such as joysticks, touch pads, track balls, a keyboard,and/or a microphone for voice commands may also be used. The secondmodule may contain a camera to store pictures that may be displayed onthe second module display. The display may be adapted to display one ormore icons. The user may use the input device(s) to select icons and/or,in the case of a touch screen display, the user may select the icons bytouching the display at the locations of the icons he wishes to select.There can be any number of kinds of icons, for example, icons couldinclude basal icons, bolus icons, sensor trend icons, food index and/ornutritional index icons, data transfer icons, power icons, settingsicons, log book icons, alarm icons, exercise icons, sleep icons, eaticons, favorites, icons, most recent use icons, and so forth. The iconspresented on the user interface may be customizable to represent aparticular thing that the user, a patient, doctor, parent, or otheruser, may want to do. For example, a doctor may wish to include an iconfor a temporary basal rate that a patient commonly uses. In that case,the patient could activate the temporary basal rate icon to start thatparticular temporary basal rate or to go directly to a temporary basalrate screen.

It is noted that some users can be expected to have somewhat diminishedvisual and tactile abilities due to the complications from diabetes orother conditions. Thus, the display and buttons or other input devicesmay be configured and adapted to the needs of a user with diminishedvisual and tactile abilities. In alternative embodiments, the secondmodule (and/or the first module) may communicate to the user by audiosignals, such as beeps, speech or the like.

Other display settings may be customizable, including, but not limitedto, the background, sounds, fonts, and wallpaper. There may be achildren's mode, with limited features available so that a child cannotdispense too much medication at once. Different display features may beincluded in the module and/or may be downloaded from a computer. Thesecond module may have a memory with which to store customized settingsor pump control. The memory may be of any type that is known in the art,such as a volatile or non-volatile memory. Both a volatile andnon-volatile memory may be used, which can speed up operation of thepump. As an example, non-volatile memories that could be used in theinvention include flash memories, thumb drives and/or memory sticks suchas USB thumb drives, removable hard drives, and optical drives.

The second module preferably has a real time operating system (RTOS).The user interface may be a multi-national icon driven one, with orwithout text. A multi-national icon driven interface may reducedevelopment, testing, and validation time while also decreasing thelearning curve on the part of the user. Alternatively, the userinterface may be text based and may or may not incorporate scrolling toallow the user to scroll through text.

Shown in FIGS. 3-5 are a number of possible screens that may be used onthe display for a user interface in embodiments of the invention. Eachof these screens may display a specific user menu with icons that theuser may use to select different options for programming insulindelivery and/or selecting different infusion device features. The menusmay all be interrelated so that a user may navigate and access each menufrom the other menus. Each menu icon may be categorized as a “root menu”or an “active menu.” A root menu represents the previous menu that thecurrent menu derives from, or the last menu visited by the user. Thismay be shown as the icon located at the upper left corner. A white pipeline may be used to link the root menu to the current menu, shown as anicon located at the bottom left corner. An active menu represents thepresent menu selected, from which the user may choose to continueaccessing other submenus by selecting the icons displayed on the activemenu screen.

In FIG. 3, one embodiment of such a user menu is shown. The Screen Menu104 allows a user to adjust the settings of the display of the secondmodule. The root menu is depicted as a settings wheel 106 and the activemenu is depicted as a computer monitor 108. Other icons shown includethe standard contrast icon 110 and brightness icon 112. In the upperright hand corner, the information icon 114 is shown. The user mayselect the information icon 114 to query for more information about thecurrent menu items displayed. In one embodiment, the information icon isdisplayed on all of the menus.

An embodiment of another menu is shown in FIG. 4, illustrating a NotesMenu 116. The Notes Menu 116 may include several icons regardingexercise 118 and meal events 120, which the user may use to enter theseevents and factor them into the pumping schedules. In the embodiment,the root menu is depicted as a folder 122 and the active menu isdepicted as a desktop with a pen 124. The menu may also allow the userto take notes and store the notes into either the second module or thefirst module for future reference.

FIG. 5 further illustrates menus that may be included in embodiments ofthe invention. The menus may be interrelated so that each menu isaccessible from other menus. For example, in FIG. 5, a base menu isdepicted by a house icon 126, and from that menu, three other menus maybe accessed through the View menu (the active menu) 128 represented bythe eye icon 130. The three submenus may include a Pump Graph Menu 132,a Blood Glucose Reading Menu 134, and a Sensor Graph Menu 136. The PumpGraph Menu 132 shows the user a graph of the insulin delivery over aselected time. The active menu is indicated by the pump icon 138. TheBlood Glucose Reading Menu 134 shows the current blood glucose readingthat is either determined by a blood glucose meter included in thesecond module, or received or transmitted from a separate blood glucosemeter. The active menu is indicated by the blood drop icon 140. TheSensor Graph Menu 136 shows the user a graph of the sensor readings overtime. The menu may also show the calibration points 142, 144 for thesensor on the graph. The sensor readings may be received via RF. Theactive menu is indicated by the RF receiver icon 146.

The various menus allow the user to input information that iscommunicated from the second module to the first module. In a preferredembodiment, the pumping mechanism of the first module is controlled bythe second module according to the information supplied by the user. Thesecond module may communicate to the first module through RF or magneticinduction. The second module may communicate with the first modulethrough wired or wireless connections, and other methods. For example,the communication may be a direct connection, as by electrical contactsor wire. Other types of communication might include, for example, anRS232 connection, a USB connection, or a wired Ethernet connection,Bluetooth, ZigBee, 802.11 protocol, wireless local area network (LAN) ora wireless Ethernet connection.

In one embodiment, as shown in FIG. 6, the first module 200 is a pumpingmodule that includes a pump 210, a motor 208, and an alarm 222, whichare all comprised in or on a first module case 224. A display 201 may belocated on the module case 224. The first module 200 may include a powersupply 206, discussed in more detail below. The first module may furtherinclude control electronics 212 having a memory 216 to store pumpingprograms and/or commands and a processor 214 to process the commands tocontrol the pumping of the module. The first module 200 may include anoperation indicator 218, which may be a simple light or other type ofvisual signal to indicate that the pump is operating. Alternatively, theoperation indicator may be on the display 201, such as an LED display.The alarm 222 may be a tactile alarm, such as a vibrating alarm, anaudible alarm and/or a visual alarm. It is preferred that the firstmodule have at least minimum safety features, such as the alarm, thatcan indicate malfunctions.

The first module may receive instructions sent by the second moduletransmitter through its receiver 204. In some embodiments, both atransmitter and receiver may be included in the first module. Thecombined transmitter/transceiver configuration is also known as atransceiver. In this way, the first module may receive instructions fromthe second module as well as send back signals to the second module tobetter maintain fluid delivery. Likewise, the second module may includea transceiver so that both the first and second modules may send andreceive signals from one another.

The first module may have a button or switch or other input device tostop the pump in an emergency 220. To avoid the emergency stop 220 beingactivated accidentally, there may be a safety feature implemented. Forexample, if the emergency stop is a button, the stop might not beactivated until the button is pressed for a continuous period of time,for example two seconds. There may be two buttons that both need to bepressed at the same time. In further embodiments, the first module mayalso have general input devices, like buttons or keys, to inputinstructions or program fluid delivery.

Although the first module described in this embodiment is a pumpingmodule, it is envisioned that a number of different kinds of firstmodules could be used with the second module. For example, the secondmodule could work with a first module that is a continuous glucosesensor and/or a blood glucose meter.

In one embodiment, as shown in FIG. 7, the second module 100 includes aprocessor 314 in communication with a display 301. The display 301 maybe located on the module case 324. The processor 314 is also incommunication with any input device 328, such as keys or buttons. Thesecond module 100 includes a memory 316, in communication with theprocessor 314, for storing information input from the input device(s)328 and for output on the display 301, where the processor 314 andmemory 316 are part of the control electronics 312. In addition, thememory 316 is adapted to store any programs loaded as part of the pumpsoftware 326. The first module preferably has software similar to thatin the second module, but without the same user interface.

The second module may send instructions to the first module through itstransmitter 304. In some embodiments, both a transmitter and receivermay be included in the second module. The combinedtransmitter/transceiver configuration is also known as a transceiver. Inthis way, the second module may both send instructions to and receiveinstructions from the first module to better maintain fluid delivery.Likewise, the first module may include a transceiver so that both thesecond and first modules may send and receive signals from one another.

The first module, with its pumping module, preferably has a very limiteduser interface for operational and/or basal indication and emergencybolus. The second module 100 may further include a power supply 306,discussed in more detail below. The second module 100 may also includean operation indicator 318, which may be a simple light or other type ofvisual signal to indicate that the second module 100 is operating. Itmay additionally include a first module operation indicator thatindicates whether the first module 200 is operating. The second module100 may include emergency stops 320 similar to those that may beincluded in the first module 200.

The second module and the first module preferably each have their ownpower supply, although it is possible for there to be a power supply inthe first module alone, so that the second module is only connected to apower supply when it is electrically connected to the first module. Eachpower supply may be rechargeable or disposable. Where the power supplyis rechargeable, it may be a rechargeable battery. If the second modulehas a rechargeable battery, the second power supply may recharge whenthe second module connects to the first module and/or when the secondmodule is connected to another power supply. For example, the powersupply could recharge when the second module is docked in a dockingstation. The second module may be electrically connected to a poweroutlet for charging the power supply. The second module could also beconnected to a portable battery charger for charging the power supply.Additionally, the power supply could be a kinetically rechargeablebattery.

The first module, like the second module, may also have a rechargeablepower supply. If the first module has a rechargeable battery, the firstpower supply may recharge when the first module connects to the secondmodule and/or when the second module is connected to another powersupply. A battery recharger may be adapted to recharge one module at atime or both of the second module and the first module at the same time.A battery recharger could also be adapted to charge more than modules,for example for systems that include two first modules. The power supplyfor either module may be a removable battery that can be rechargedseparately from the modules. Additionally, it is possible that the firstmodule may be manufactured and sold cheaply enough that the entiremodule could be disposable at the end of a non-rechargeable batterylife. In this case, the battery may be sealed inside the module forbetter water resistance. Furthermore, the second module and/or the firstmodule themselves may be water resistant. They also may be waterproof.Alternatively, the second and first modules may be manufactured so thatthe compatibility to operate as an entire module is not limited to aspecific counterpart. In this manner, if and when the second module orthe first module breaks or is too worn to continue use, a new second orfirst module may be purchased and be compatible with the remainingcounterpart.

A power indicator may be included on the display of the second moduleand/or the first module so that the user can conveniently check thelevel of power. The indicator may provide a warning to the user as towhen the power supply needs to be recharged or replaced. For example,the intensity of the indicator may correlate with the power level. Inaddition, a warning indicator may notify the user that the power supplyis very low or about to run out by blinking.

In embodiments where the first module is a pump module and is disposableafter a period of time, the first module may be pre-filled with thefluid for infusing and intended for a single infusion of fluid. Once allof the fluid has been infused, the first module may be disposed. Forexample, if the first module holds three days worth of fluid, it wouldbe disposable after three days of use. The amount of fluid includedcould be equal to the average amount that would be used during theaverage lifetime of the included battery. Alternatively, more fluid orless fluid could be included so that the battery would likely run outfirst or so that the fluid would likely run out first. In still otherembodiments, the first module may be refillable as to the fluid, butinclude a non-rechargeable battery that is sealed within the housing. Inthat case, the first module could be disposable at the end of thebattery life. The life of the first module would generally depend on thetype of battery used.

The modules may include a number of ways to increase battery life. Forexample, one or more module could include solar cells to increase thelight of the displays and to increase power. In further embodiments, thedisplay may be configured to turn off after a certain amount of time,which may be preset or set by the user. Alternatively, the display mayremain on at all times. It may be an option selectable by the user forthe display to either remain on at all times or to turn off after acertain amount of time. The entire second module could also beconfigured to turn off after a certain amount of time to save power.Where the second modules inputs a schedule into the first module and isnot needed until the next input from the user, it is not necessary forthe second module to remain on at all times.

The second module may be used in conjunction with the first module, forexample to control the pumping features, or it may also be used forstand-alone applications, such as sensing an analyte level of thepatient. The second module may have a sensor interface, an analytemeter, or both. The analyte may be, for example, blood glucose. And thesensor may be, for example, a continuous glucose sensor. Example glucosesensors are described in U.S. Pat. Nos. 5,390,671; 5,391,250; 5,482,473;and 5,586,553, and U.S. application Ser. No. 10/273,767 (published asU.S. Patent Publication No. 2004/0074785 A1, on Apr. 22, 2004), whichare herein incorporated by reference. While the blood glucose meter maybe housed in the second module, it is also possible that the secondmodule has a receiver, in addition or instead of the blood glucosemeter, to receive information transmitted from a separate blood glucosemeter. In further embodiments, the first module may be a sensing deviceor a blood glucose meter. In still further embodiments, the secondmodule may be adapted to interface with two or more first modules. Forexample, in one embodiment, a blood glucose meter, by itself orincluding a continuous glucose sensor, is adapted to be a second firstmodule. The modules may stack upon each other, like a sandwich, so thatthe one of the first modules is sandwiched between the other firstmodule and the second module. Alternatively, the modules may be wornseparately or side-to-side from each other.

In particular embodiments of the invention the first module has one ormore alarms. The second module may also have one or more alarms. Alarmsmay be audible, tactile, and/or visual. Alarms may indicate low or highblood glucose levels, pumping problems like blockages or overdelivery offluids, lack of communication between devices, or power failure, forexample. In embodiments, the alarm may sound whenever blood glucoselevels go beyond a programmed or allowed range. The range may beselected and inputted manually by a user or the range may be calculatedbased off of a set of governing parameters. The second module mayinclude a speaker, which may be configured to output alarms or othersounds. The sounds may sound like a buzzer or another noise. They may bewords. For example, if the user's blood glucose is high, an alarm maysound that says, “your blood glucose is high.”

The first module can be used with or without the second module. It ispreferably compact so that it can be worn under clothing if desired. Itpreferably can operate semi-independently from the second module whilekeeping in contact with it. The first module preferably has a minimaluser interface. In one embodiment, it may only have a power switch oron/off button. Where the first module is a pumping module, the firstmodule may instead include an emergency stop button or switch in casethe pump alarms. In further embodiments, the first module may include asimple display, such as an LED display, and/or one or more buttons. Forexample, where the first module is a pumping module, the display maydisplay the pumping rate of the module and the user may use one or morebuttons or keys to change the pump rate. In further embodiments, thepumping module may be adapted to display several characteristics of thepumping program, which the user could scroll or select through using oneor more buttons or keys. In still further embodiments, the display maybe more sophisticated, like an LED or OLED, for example, and/or thefirst module may include additional or different input devices, such asjoysticks, touch pads, track balls, a keyboard, and/or a microphone.

The second module and the first module may use any number ofcommunications protocol. One or both of the second module and the firstmodule may communicate to a personal commuter. The communication may bewired or wireless. For example, the modules may communicate with thecomputer when inserted into a docking station or when connected by awire to the computer. The communication may be wireless, such as RF,Bluetooth, or any other wireless method. Other types of communicationmight include, for example, an RS232 connection, a USB connection, or awired Ethernet connection, Bluetooth, ZigBee, 802.11 protocol, wirelesslocal area network (LAN) or a wireless Ethernet connection. The secondmodule and/or the first module may be configured to interact with ananalyte sensor. For example, the second module may to communicate with ablood glucose sensor and/or a glucose meter as well. The sensor may be acontinuous glucose sensor. The communication between the second moduleand the blood glucose sensor and/or glucose meter may also be wired orwireless.

The second module and/or the first module may be configured to notifythe user if there are communication problems between any of the devices.When strict medication delivery and monitoring is required, for examplea closed-loop system, the first module can be programmed to stopdispensing medication when it fails to receive periodic scheduledcommunication from the second module or a personal computer (PC) or thelike. In alternative, an alarm may sound when the scheduledcommunication is not received, rather than stopping the medicationdispense. This timeout option and duration is programmable and may alsobe included in the delivery schedule. The notification may be of one ormore types, such as an alarm, an icon on the display, or some other typeof notification.

The first module may also be configured to communicate with a bloodglucose meter or a blood glucose sensor in the case of a virtual secondmodule. The first and/or second module may further be configured tocommunicate with implantable devices such as an implantable insulin pumpor an implantable blood glucose sensor. The first and/or second modulemay also communicate and transfer user settings, history data, newsoftware or firmware, and configuration information with other firstand/or second modules or PCs. This would allow for system replacementsand software upgrades. The first and/or second module may alsocommunicate to more than one pump or sensor modules.

The second module may have an on-pump training mode, so that a user maylearn how to use the pump interactively, without having to actuallydispense medication. In the on-pump training mode, the second moduleteaches the user to go through the steps that the user would take toperform an action using the second module. The on-pump training mode maybe a mode that is only able to be activated when the second module isseparated from any first module. Alternatively, the on-pump trainingmode may be set up so that a user can enter the training mode at anytime. For example, if a user is learning to use a temporary basal rateoption, the user might want to enter the training mode to getinstruction directly from the second module, instead of from a manual.In further embodiments, the on-pump training mode may allow the user todirect the second module to perform the actions taken during thetraining mode. For example, during a training session in which the userlearns to use a temporary basal rate option, the user may select atemporary basal rate and a time period for delivery of the temporarybasal rate option. At the end of the training session, the pump mayquery the user to determine whether the user wants to run a program sothat the pump can proceed at a selected temporary basal rate for aselected time period. If the user selects to run the program, the secondmodule sends an instruction to a first pumping module to pump theselected temporary basal rate for the selected time period. If the userselects to not run the program, the second module does not send aninstruction to a first pumping module.

In an embodiment where the second module communicates with a glucosesensor and the first module, it is anticipated that a closed-loop systemmay be employed. In a closed-loop system, the pump interacts with acontinuous glucose sensor to mimic the functions of a healthy pancreas.Preferably, the system works with minimal interaction from the patient.An example of a closed loop system is described in U.S. Pat. No.6,558,351, which is herein incorporated by reference.

Additionally, one or both of the second module and the first module maycommunicate with other devices, such as a phone or pager system. Infurther embodiments, the second module and/or the first module mayinclude a Global Positioning System (GPS) device. Alternatively, thesecond module and/or the first module may interface with a GPS device.The GPS device can be configured to help the user determine his or herlocation or get directions to another location, like a standard GPSdevice used in an automobile. The GPS device can also be used to locatea user from a remote location. For example, if a user has a bloodglucose emergency, emergency personnel could use the GPS device to findthe user. The GPS may be always on, or intermittently, for example ableto be turned on by the user, or turned on automatically if a problemexists.

In further embodiments, there is a computer software program that isessentially a virtual second module. The same commands and controls thatexist in the second module may exist in the computer program. The secondmodule may be synched with the computer program on the computer, so thatchanges made on the computer are indicated in the second module, andvice versa. In still further embodiments, the second module may beadapted to interact with a virtual patient software program that allowsa patient and/or a doctor to change different parameters and see how itwould affect the patient. The virtual patient software program mayreceive data from the second module to populate the program parameters.An example of a virtual patient software program is described in pendingU.S. Patent Application No. 40088-316103, entitled “Virtual PatientSoftware System for Educating and Treating Individuals with Diabetes,”filed Jun. 3, 2005, attorney docket no. 11/145,485, which is hereinincorporated by reference.

Additional software may be used on the computer for keeping records andanalysis of patient data, such as tracking medication delivery, etc. Thesoftware may include graphing capabilities and spreadsheets and otherdata displays. In certain embodiments, the second module is configuredto display information from the software on the computer. For example,the second module may be configured to display a graph of medicationdelivery over a certain time, such as the basal delivery for the pasttwenty-four hours. In another embodiment, the first module may becontrolled from a remote location, the remote location being a PC.

While the description above refers to particular embodiments of thepresent invention, it will be understood that many modifications may bemade without departing from the spirit thereof. The accompanying claimsare intended to cover such modifications as would fall within the truescope and spirit of the present invention.

The presently disclosed embodiments are therefore to be considered inall respects as illustrative and not restrictive, the scope of theinvention being indicated by the appended claims, rather than theforegoing description, and all changes which come within the meaning andrange of equivalency of the claims are therefore intended to be embracedtherein.

What is claimed is:
 1. An external infusion device for infusing a fluidinto a user's body comprising: a portable first module configured to beworn by the user, the first module including: a first housing; an alarmin the first housing; a reservoir in the first housing to hold a fluid;and a pump in the first housing to pump the fluid from the reservoir;and a portable second module configured to removably attach to the firstmodule so as to form a unitary portable device, the second moduleincluding: a second housing; a display in the second housing; and asensor interface, the sensor being a continuous glucose sensor, whereinthe second module communicates with the first module to provide a fluiddelivery program for the flow of the fluid from the first housing,wherein the unitary portable device is configured to be worn under theuser's clothing, and wherein the alarm is triggered when communicationbetween the second and the first modules is disrupted.
 2. The externalinfusion device of claim 1, wherein the alarm is also triggered whenthere is a pump blockage or when a malfunction is detected.
 3. Theexternal infusion device of claim 1, wherein the alarm is selected fromthe group consisting of a tactile alarm, an auditory alarm, and a visualalarm.
 4. The external infusion device of claim 1, wherein the secondmodule is configured to removably attach to the first module by at leastone of sliding onto the first module, snapping onto the first module,and hook and loop fasteners.
 5. The external infusion device of claim 1,wherein the first module further includes a memory to store the fluiddelivery program, a processor to retrieve the fluid delivery programfrom the memory and to control the pumping of the fluid from the firstreservoir, and at least one power supply that provides power to actuatethe pump.
 6. The external infusion device of claim 5, wherein the memoryis a flash memory and the at least one power supply is a rechargeablebattery.
 7. The external infusion device of claim 1, wherein the displayis touch sensitive and is configured to display various icons with whichthe user programs the infusion of fluid into the user's body.
 8. Anexternal infusion device for infusing a fluid into a user's bodycomprising: a portable first module configured to be worn by the user,the first module including: a first housing; an alarm in the firsthousing; a reservoir in the first housing to hold a fluid; and a pump inthe first housing to pump the fluid from the reservoir; and a portablesecond module configured to removably attach to the first module so asto form a unitary portable device, the second module including: a secondhousing; a display in the second housing; and a blood glucose meter,wherein the second module communicates with the first module to providea fluid delivery program for the flow of the fluid from the firsthousing, wherein the unitary portable device is configured to be wornunder the user's clothing, and wherein the alarm is triggered whencommunication between the second and the first modules is disrupted. 9.The external infusion device of claim 8, wherein the alarm is alsotriggered when there is a pump blockage or when a malfunction isdetected.
 10. The external infusion device of claim 8, wherein the alarmis selected from the group consisting of a tactile alarm, an auditoryalarm, and a visual alarm.
 11. The external infusion device of claim 8,wherein the second module is configured to removably attach to the firstmodule by at least one of sliding onto the first module, snapping ontothe first module, and hook and loop fasteners.
 12. The external infusiondevice of claim 8, wherein the first module further includes a memory tostore the fluid delivery program, a processor to retrieve the fluiddelivery program from the memory and to control the pumping of the fluidfrom the first reservoir, and at least one power supply that providespower to actuate the pump.
 13. The external infusion device of claim 12,wherein the memory is a flash memory and the at least one power supplyis a rechargeable battery.
 14. The external infusion device of claim 8,wherein the display is touch sensitive and is configured to displayvarious icons with which the user programs the infusion of fluid intothe user's body.